Dapagliflozin Tablet 10 mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dose of this medication is 10 mg once daily for monotherapy and additional adjunctive therapy with insulin or other antidiabetic agents. In initial combination therapy, if there has been no prior experience with antihyperglycemic agents, the initial doses when combined with metformin is 5 mg or 10 mg once daily. For patients with chronic heart failure and chronic kidney disease, the recommended dose is 10 mg once daily.

Child dose

The efficacy and safety of dapagliflozin in children under 18 years of age have not been established. No relevant data exists.

This medication should not be used in certain patients. It is contraindicated in patients with allergies to the main ingredient or excipients, type 1 diabetes, diabetic ketoacidosis, and patients with lactose intolerance or related genetic disorders. Moreover, it should not be used in patients undergoing dialysis. Caution is advised when administering to patients with reduced fluid volume or renal impairment. This medication can lower blood pressure or reduce intravascular fluid volume, posing a risk of symptomatic hypotension or acute kidney injury. In particular, patients with diminished renal function, elderly patients, and those on diuretics should be closely monitored for fluid status and renal function before and after administration. Adverse effects of this medication may occur. The most common side effect is genital infections, which occur more frequently in females and those with a history of infections. Other reported side effects include hypoglycemia, fluid volume depletion, dizziness, dry mouth, urinary tract infections, and dysuria. Increased serum creatinine associated with renal function should also be monitored. This medication can cause a serious metabolic acidosis known as ketoacidosis. Ketoacidosis may occur even if blood sugar levels are not high, so if symptoms such as nausea, vomiting, abdominal pain, lethargy, or dyspnea arise, medical consultation should be sought immediately. The risk of serious urinary infections such as urinary tract infections and pyelonephritis may increase, so prompt treatment is necessary if infection symptoms occur. Elderly patients or those with reduced renal function are particularly at higher risk for fluid volume depletion and hypotension. The risk of hypoglycemia may increase when this medication is used with insulin or sulfonylureas, so dose adjustments for these medications may be necessary. Pregnant or breastfeeding women are advised not to use this medication and should discontinue use if pregnancy is confirmed. There is no specific antidote for overdose; however, appropriate treatment should be provided based on the patient's condition, and it is unknown whether this medication is removed by dialysis. When taking this medication, it does not significantly affect driving or machinery operation, but caution is advised in cases where there is a risk of hypoglycemia. Lastly, the safety and efficacy of this medication in children have not been established, and it is important to keep it out of the reach of children and store it in its original container.

Serious side effects

Acute kidney injury, severe hypotension, diabetic ketoacidosis, Fournier's gangrene, urinary sepsis, pyelonephritis, anaphylaxis, hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, paleness, severe rash with fever and blisters, peeling skin, mucosal pain in the mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory distress with cough and fever

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, dizziness, constipation, dry mouth, low back pain, dysuria, polyuria, nocturia, interstitial nephritis, increased hematocrit, reduced renal creatinine clearance at the start of treatment, dyslipidemia, increased serum creatinine at the start of treatment, elevated blood urea, weight loss, indigestion, nausea, diarrhea, vomiting, vaginal discharge, itching, hives, eating

This medication should be stored in a tightly sealed container to protect it from air and moisture. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius.

Appearance

Yellow, bi-convex, diamond-shaped film-coated tablets

Package unit

28 tablets/box (14 tablets/PTP x 2)